From concept to working prototype — with the regulatory architecture built in.

Most medical device product development failures share a common cause: regulatory requirements were treated as a downstream concern, something to address once the device "works." The result is a prototype that performs well clinically but has no design history file, no traceability from user needs to design outputs, no formal risk analysis tied to design decisions, and no verification testing plan. Retrofitting regulatory documentation to a device that was already built is expensive, slow, and often results in design changes that break what was working.

When you build with us, the design controls framework (ISO 13485:2016 Clause 7.3) is the project management framework. Every design input is documented. Every design output is traceable to an input. Every design change goes through a formal impact assessment. The design history file (DHF) grows in real time alongside the device, so by the time you have a prototype, you also have a complete regulatory record of how it was built.

We are not a design agency. We are a technical and regulatory team that builds medical devices. Our engineers are familiar with IEC 60601-1, ISO 14971, IEC 62304, and IEC 62366 because we have taken devices through those standards to market. Design decisions are made with the regulatory end state in mind from the first drawing.

We design electronic hardware for electromedical devices to IEC 60601-1 requirements from the schematic stage. Applied part classification, creepage and clearance distances, means of operator and patient protection, and essential performance considerations are built into the hardware architecture — not tested at the end and found wanting. PCB design review includes both functional and regulatory checks before fabrication.

Embedded software and firmware is developed under an IEC 62304-compliant software development lifecycle. Software safety classification, software requirements specification, software architecture document, detailed design, unit implementation, and integration testing are all documented in formats accepted by notified bodies and FDA software reviewers. We maintain the SOUP (Software of Unknown Provenance) list, configure management under a version control system, and produce the verification and validation documentation.

ISO 14971:2019 risk management is integrated into design activities, not conducted as a separate project after design is complete. As design inputs are defined, hazards are identified. As design outputs are generated, risk controls are specified and verified. Residual risk is assessed before design validation, not after the device is already in the hands of clinical users.

Usability engineering under IEC 62366-1:2015+AMD1:2020 defines the process for identifying use errors and critical tasks, designing the user interface to mitigate them, and validating that the design works for the intended user population. For devices with a clinical user interface — a display, controls, alarms, or a patient-facing interaction — we integrate usability activities into the development programme from formative studies through summative evaluation.